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Polytopic Cream (2015-02-19)
- Starting date:
- February 19, 2015
- Posting date:
- February 24, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43871
Recalled Products
Polytopic Cream
Reason
Product recalled due to Out of Specification result for the ingredient Polymixine B at 18 months stability testing.
Depth of distribution
Wholesalers
Affected products
Polytopic Cream
DIN, NPN, DIN-HIM
DIN 00422908
Dosage form
Cream
Strength
Gramicidine 0.25 mg/g
Polymyxine B 10000 unit/g
Lot or serial number
667906
Companies
- Recalling Firm
-
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA